As part of its responsibility for protecting public health, the U.S. FDA conducts unscheduled inspections of establishments that manufacture medical devices. As a public entity, FDA provides a lot of information on what to expect during an inspection, how to prepare and what’s required after the inspection.
The inspection is based on the requirements under the Quality Systems Regulation (QSR) or 21CFR820 and the inspectional process called Quality System Inspection Technique (QSIT) differs substantially from ISO 13485 and other globally harmonized quality system standards. In some cases, whether they are new to the US market or new to the medical device industry, companies find themselves substantially unprepared for the FDA inspection
In this 70 minute pre-recorded webinar, “FDA Just Called! Now What?” UL and MasterControl experts with over 60 years combined FDA Inspection experience provide practical information on specific actions to take to help prepare for an FDA Inspection. They use real-life examples and respond to questions from the audience real-time.